Structured Product Labeling Services

Overview - Structured Product Label

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.(1)

US FDA adopted SPL technology for processing and managing labeling and labeling changes, including the content of labeling submitted electronically. In the year 2005 FDA released Guidance for Industry “Providing Regulatory Submissions in Electronic Format — Content of Labeling” for submitting the content of labeling using the Structured Product Labeling (SPL) standard, which is based on extensible markup language (XML).

The guidance addresses the issues related to the submission of labeling content in electronic format for marketing applications for human drug and biologic products, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) for biological products that meet the definition of drug in US’s Federal Food, Drug, and Cosmetic Act.(2)

DDReg’s team of highly qualified and experienced labelling professionals not only author & develop package inserts & medication guides for submission to US FDA, but they are also highly competent in converting them to XML-format SPL files, while maintaining compliance with the FDA guidelines. We provide seamless support to various pharmaceutical organizations including but not limited to healthcare, medical device , and biopharmaceutical organizations, in converting their labels to validated SPLs, and conduct version-controlled processes to manage the SPL life cycle in accordance with the FDA requirements and specifications.

Basics of Structured Product Labeling Services

Structured product labeling services have become an integral component of regulatory frameworks in the pharmaceutical industry. Structured product labeling refers to the standardized format used for presenting product information. It is a system that is designed to enhance the accuracy, consistency, and efficiency of information exchange for pharmaceutical products labels .

Dissemination of precise and uniform information is critical in the pharmaceutical industry; structured product labeling services streamline the creation, submission, and management of pharmaceutical product data. This structured approach ensures that information related to drugs is consistently formatted, facilitating its integration into regulatory submissions and health information systems. This helps expedite regulatory review processes and enhances the accuracy of product information.

Indeed, the adoption of structured product labeling in the pharmaceutical sector has far-reaching implications for regulatory compliance. Regulatory bodies like the US FDA leverage structured product labeling to standardize the presentation of critical information in product submissions. This facilitates more efficient review processes and supports regulatory authorities in their oversight responsibilities.

Structured product labeling services provide a cohesive framework for managing diverse product information including dosage, indications, contraindications, and adverse reactions. This uniformity is particularly crucial in regulatory affairs services where precision and consistency are essential for regulatory compliance.

Structured product labeling services are a linchpin for maintaining data consistency, accuracy, and adherence to regulatory standards. By adopting structured product labeling, the pharmaceutical sector ensures that regulatory eCTD submissions are more efficient, accurate, and compliant.